Device Classification Name |
System, Imaging, Pulsed Doppler, Ultrasonic
|
510(k) Number |
K202216 |
Device Name |
EPIQ Series Diagnostic Ultrasound Systems |
Applicant |
Philips Ultrasound, Inc. |
22100 Bothell Everett Highway |
Bothell,
WA
98021 -8431
|
|
Applicant Contact |
Colin S. Jacob |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
Prithul Bom |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/06/2020 |
Decision Date | 09/02/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|